1. Field of the Invention
This invention relates generally to a method of making a hemostatic plug for placement at a site where hemostatic treatment is indicated such as a puncture wound, and in particular to a method for making the plug wherein the plug comprises a rolled sheet of a hemostatic material which tends to unfurl after placement in a wound cavity and thereby fill the wound cavity.
2. Discussion of the Prior Art
Hemostatic treatment can be indicated at a variety of sites where a patient exhibits bleeding. An example of such a site occurs when performing angioplasty, angiography, or other procedures requiring establishment of an entry into a blood vessel of a patient. After such a procedure, it is necessary to effectuate closure of the resulting puncture wound upon withdrawal of instrumentation employed in performing the medical procedure and in maintaining the puncture entry of the blood vessel. Traditional approaches employed to promote wound closure include hand pressure, pressure bandages, clamps and the like to maintain pressure over the region of the wound for a time sufficient to stop bleeding. U.S. Pat. Nos. 4,852,568, 4,890,612, 4,838,280 and 4,936,835 disclose the use of a plug made of a solid mass of a hemostatic material for placement at the wound site. Co-pending application Ser. No. 912,921, filed Jul. 13, 1992, and assigned to the same assignee as the present invention and incorporated herein by reference, teaches a hemostatic plug having an opening throughout its longitudinal axis so that it can be accommodated and placed in coaxial relationship with a novel implant introducer device described and claimed in that application. Except for the opening along its longitudinal axis, the plug described in the co-pending application is constructed from a solid mass of hemostatic material.
Because speed is of the essence in closing a puncture wound to thereby stop bleeding, it is advantageous to have hemostatic material whose configurations and characteristics cause rapid and effective wound cavity occupation and blood flow stoppage.
It is therefore a primary object of the present invention to provide a method of making a hemostatic plug which rapidly fills a wound cavity and which provides advantageous surface area presentment to promote hemostasis.
Another object of the present invention is to provide a method of making a hemostatic plug constructed from a sheet of a hemostatic material rolled upon a cylindrical forming tool whereby the plug subsequently unfurls in a wound cavity to thereby fill the cavity and increase cavity pressure while presenting advantageous surface area for fluid absorption and blood flow cessation.
Still another object of the present invention is to provide a method of making a hemostatic plug from one sheet of single density hemostatic material or from two separate sheets of hemostatic material having two different densities.
These and other objects of the present invention will become apparent throughout the description which now follows.